Predicting Immunotherapy Efficacy in Head and Neck Squamous Cell Cancer

NCT05296135 | Withdrawn

• 1 other identifier: PREDAPT-HNSCC-2
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the clinical validity and clinical utility of the OncoPrism-HNSCC (Head and Neck Squamous Cell Carcinoma) test.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate: Inter-interval

  Inequality comparison of the linearly increasing Disease Control Rate of patients assigned to OncoPrism-HNSCC quarters 1, 2, 3, and 4.

  through Final Analysis cutoff date of Dec 1, 2023

Secondary Outcomes (2)

• Disease Control Rate: Inter-interval 2

  through Final Analysis cutoff date of Dec 1, 2023

• Sensitivity: OncoPrism-HNSCC vs PD-L1 IHC

  through Final Analysis cutoff date of Dec 1, 2023

Study Arms (1)

Main Cohort

Diagnostic Test: OncoPrism-HNSCC™

Interventions

OncoPrism-HNSCC™ DIAGNOSTIC_TEST

OncoPrism-HNSCC™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Main Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recurrent and metastatic Head and Neck Squamous Cell Carcinoma patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled.

You may qualify if:

• Subject must have been diagnosed with recurrent or metastatic HNSCC.
• Subject must have received, or be scheduled to receive, at least one dose of FDA approved anti-PD-1/PD-L1 immunotherapy for treatment of their cancer.
• Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
• Subject must have a RECIST determination of PD-L1/PD-1 inhibitor-treatment by imaging or clinical assessment.
• Willing to provide electronic informed consent per IRB-approved protocol.
• Able to speak, read, and comprehend English or Spanish fluently.
• Subject is 18 years of age or older.
• Subjects must have sufficient tissue available to fulfill the specimen requirements of the study, as defined in the Specimens to be Collected section of protocol.

You may not qualify if:

• Subject shall not have received immunotherapy in combination with other therapy modality such as radiation therapy, platinum-based chemotherapy, or a taxane.
• Subject shall not have received immunotherapy outside of FDA approved use as of the date of this protocol.
• Subject shall not have inability or unwillingness to provide informed consent.
• Subject shall not have other cancers than listed above (other histologies).
• Subject shall not have already participated in this trial.
• Subject specimens shall not have \<10% tumor cellularity measured by H\&E.
• More than 24 months shall not have transpired between biopsy harvest and studied immunotherapy treatment.

Sponsors & Collaborators

• Cofactor Genomics, Inc.: lead

Study Sites (1)

Curebase

San Francisco, California, 94131, United States

Location

Related Publications (1)

• Flanagan KC, Earls J, Hiken J, Wellinghoff RL, Ponder MM, McLeod HL, Westra WH, Vavinskaya V, Sutton L, Deichaite I, Macdonald OK, Welaya K, Wade J 3rd, Azzi G, Pippas AW, Slim J, Bank B, Sui X, Kossman SE, Shenkenberg TD, Alexander WL, Price KA, Ley J, Messina DN, Glasscock JI, Colevas AD, Cohen EEW, Adkins D, Duncavage EJ. Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study. J Immunother Cancer. 2024 Nov 3;12(11):e009573. doi: 10.1136/jitc-2024-009573.

  PMID: 39489541 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 25, 2022
• Study Start: February 5, 2020
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)